FDA IDE Approval for Trial of GI Surgical Sealant

Israeli tissue repair company, LifeBond says it has received a U.S. FDA Investigational Device Exemption (IDE) approval to initiate a clinical study of the LifeSeal® Surgical Sealant Kit, which includes a unique gastrointestinal (GI) sealant specifically designed to minimize staple-line leakage in gastrointestinal resection procedures.

Background

LifeBond’s first product, LifeSeal, is designed to provide staple-line reinforcement in GI surgery where, once applied over colorectal staple-lines, it forms an elastic yet firm protective layer, which is designed to maintain sealing during the critical post-operative period. Reducing leakage has the potential to save patient lives, improve patient recovery and avoid re-admissions and repeated surgeries. The unmet need clearly exists, anastomotic leakage after a colorectal resection being associated with significant mortality and morbidity, yet companies have thus far failed to demonstrate safety and efficacy, not least because of the difficulties in developing clinically relevant models. The IDE study, which has already started enrolling in Europe, should clarify can support their technology with clinical outcomes.

The FDA trial is designed to be a multicenter, multinational, randomized, double arm, single-blind study that will evaluate the safety and efficacy of the LifeSeal Surgical Sealant Kit. The study will be conducted at leading medical centers in the US and Europe.

Company comments

“Given the associated challenges and complications of low anterior resections (LAR), developing a sealant for preventing leakage in GI resection procedures is an extremely ambitious undertaking since leakage rates can reach more than 20%,” said Dr. Sachi Norman, Chief Medical Officer at LifeBond. “LifeBond’s LifeSeal is designed to address these challenges. EU clinical study data demonstrated a trend in leakage reduction with more than twice the number of leaks occurring in patients with standard treatment compared to LifeSeal treated patients – 8 verses 3 leaks in 70 patients. These results indicate that LifeSeal has great potential to improve patient outcomes following colorectal resection procedures.”

“Today’s news marks a major milestone in the development of LifeSeal. The FDA’s nod firmly validates the importance and the maturity of the product as well as its rigorous development to date,” said Mr. Gideon Sturlesi, CEO of LifeBond. “We are delighted to have the support of the FDA to begin a larger trial to further confirm existing findings and to inch closer to bringing this important product to the market in the U.S. as well.”